9 results
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18ms
·
Sources: EU EUDAMED, US FDA
LEVTECH CLAMP APPLIER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GC Initial™
FDA UDI
Gc America Inc.·J0228740231·GC Initial™ Ti Gingival Universal Refill GO-U,...
GC Initial™
FDA UDI
Gc America Inc.·15400556704797·GC Initial™ AL Dentin DA3, 20g
BIO-SCIENCE LABORATORIES T4 REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AQUAFORM ELECTRODES WITH AQUAPORE
FDA 510(k)
FDA Class 2
·Neurology
SYNERGEYES HYBRID DAILY CONTACTS - PS
FDA Adverse Event
Injury
·SYNERGEYES·Product code HQD·June 5, 2014
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 15, 2010
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code LEH·December 14, 2012
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013